Medical device licence · 106205 · Class 3
STAT PROFILE PRIME PLUS ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed June 7, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106205
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 7, 2021
- Devices covered
- 39
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LINEARITY STANDARD SET G MULTIPACK
- LINEARITY STANDARD SET G MULTIPACK LEVEL 1, LEVEL 2
- NOVA LINEARITY CREATININE/BUN/HCT LEVEL 1, 2, 3, 4
- STAT PROFILE PRIME PLUS (CLASS III)
- STAT PROFILE PRIME PLUS (REMANUFACTURED)
- STAT PROFILE PRIME PLUS AMPULED CONTROLS CHEMISTRY AMPULED CONTROL
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 105 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 160 SAMPLE
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 210 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 315 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 320 SAMPLE
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE 480 SAMPLE
- STAT PROFILE PRIME PLUS AUTO QC CARTRIDGE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS BLOOD GAS, CO-OX AMPULED CONTROLS
- STAT PROFILE PRIME PLUS BUN, CREATININE - BLANK SENSOR CARD
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 100 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 100 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 200 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 200 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 300 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 300 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 400 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 400 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 500 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 500 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 700 SAMPLE
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE 700 SAMPLE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CALIBRATOR CARTRIDGE WITH CREAT/BUN
- STAT PROFILE PRIME PLUS CHEMISTRY AMPULED CONTROL 4, 5
- STAT PROFILE PRIME PLUS MICROSENSOR CARD
- STAT PROFILE PRIME PLUS MICROSENSOR CARD (HIGH VOLUME)
- STAT PROFILE PRIME PLUS MICROSENSOR CARD 100
- STAT PROFILE PRIME PLUS MICROSENSOR CARD BUN, CREATININE
- STAT PROFILE PRIME PLUS MICROSENSOR CARD WITH COOX
- STAT PROFILE PRIME PLUS MICROSENSOR CARD WITH COOX (HIGH VOLUME)
- STAT PROFILE PRIME PLUS MICROSENSOR CARD WITH COOX 100
- STAT PROFILE PRIME PLUS REFERENCE CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.